SARNS DELPHIN BASE ADAPTER WITH BATTERY— 510(k) K902198

Substantially Equivalent

3M Company

FDA 510(k) clearance K902198 for SARNS DELPHIN BASE ADAPTER WITH BATTERY, Substantially Equivalent on 1990-07-13. Applicant: 3M Company.

Clearance details

Applicant: 3M Company
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 1990-05-16
Decision date: 1990-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.